Advancing Honest and Ethical Medical Research
www.ahrp.org
FYI
A lawsuit has been filed on behalf of 5 infants against the University of Alabama, the lead medical center among the 23 at which the experiment was conducted.
Experiments such as SUPPORT—and similarly designed experiments conducted on critically ill patients in intensive care units—represent an extreme breakdown in medical research ethics.
Read the details: http://www.ahrp.org/cms/content/view/918/9/
www.ahrp.org
FYI
A
legitimate research
question: what is the
appropriate amount of oxygen an
essential therapy for fragile premature infants? Too much
oxygen therapy could
cause blindness and to little death?
An
illegitimate research
protocol: the
extremely low weight premature infants—whose mortality rate
is 20% if treated with the best current
practice--were randomized to be maintained at either
high oxygen saturation SOP2 (91-95%) or low (85-89%) oxygen
saturation, whereas
normally the full range of oxygen saturations was used.
The level usually selected to be maintained based on trying to give the minimal oxygen necessary to prevent blindness while maintaining adequate oxygen delivery so the neonate will survive.
The level usually selected to be maintained based on trying to give the minimal oxygen necessary to prevent blindness while maintaining adequate oxygen delivery so the neonate will survive.
The researchers reported in The New England
Journal of Medicine:
"our
data
suggest that there is one additional death for
approximately every two
cases of severe retinopathy that are prevented.”
Update: The most
disturbing fact that has emerged about the neonatal
SUPPORT
trial design--described in the PROTOCOL-is that the pulse oximeter readings of oxygen levels that
treating
neonatologists rely on to determine an infants’ need for
supplementary oxygen, was deliberately altered to give either false high or
false low oxygen saturation levels.
I’m not making this
up! See the SUPPORT protocol: http://www.nih.gov/icd/od/foia/library/Protocol.pdf
A lawsuit has been filed on behalf of 5 infants against the University of Alabama, the lead medical center among the 23 at which the experiment was conducted.
Experiments such as SUPPORT—and similarly designed experiments conducted on critically ill patients in intensive care units—represent an extreme breakdown in medical research ethics.
This case sheds light on
the profound chasm between the patient-centered objectives of
practicing
critical care specialists, and the objective of research whose
protocols are
not guided by ethical principles and patient / subject’s best
interest.
Read the details: http://www.ahrp.org/cms/content/view/918/9/
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